A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder

Vieta, E. and Montgomery, S. and Sulaiman, A.H. and Cordoba, R. and Huberlant, B. and Martinez, L. and Schreiner, A. (2012) A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder. European Neuropsychopharmacology, 22. pp. 825-835.

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Abstract

The efficacy and safety of risperidone long acting injectable (LAI) for preventing recurrence of mood episodes in patient with bipolar| disorder was evaluated in a randomized, placebocontrolled study. After a 12 week pen label period with risperidone LAI (n=560), patient who did not experience a recurrence entered an 18 month randomized, double-blind period with risperidone LAI(n=132)orplacebo(n=135) a third treatment arm (n=131) was randomized to oral olanzapine (10mg/day) for reference and exploratory comparisons. The primary efficacy endpoint was time to recurrence of any mood episode for risperidone LAI versus placebo in the double-blind period(Kaplan Meieranalysis).Additional efficacy endpoints included Young Mania Rating Scale,Montgomery–Asberg Depression Rating Scale and Clinical Global Impression. During the double-blind period,dosing was fixed at patients’ final open-label dose(25mg,66%ofpatients; 37.5mg,31%;50mg,4%). The primary outcome demonstrated a median time to mood episode recurrence of 198day in the place boarm, where as the median was not reached in the risperidone LAI arm (p=0.057). Time to recurrence of any mood episode was significantly longer with risperidone LAI versus placebo(log-rank test stratified by regiononly, p=0.031);the difference was significant for time to recurrence of elevated mood episodes (p=0.005)but not depressive episodes (p=0.655). Significant improvement of manic symptoms and global.

Item Type: Article
Additional Information: Correspondingauthor. Tel.:+34932275400;fax:+34932275477. E-mail address: evieta@clinic.ub.es(E.Vieta).
Uncontrolled Keywords: Atypical antipsychotics; Bipolar disorder; Long-acting injectable; Placebo-controlled trial; Recurrence; Risperidone
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Ms. Norhamizah Tamizi
Date Deposited: 17 Apr 2014 06:53
Last Modified: 17 Apr 2014 06:53
URI: http://eprints.um.edu.my/id/eprint/9627

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